510(k) · Cleared
ClearedHealgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · NFW Test, Cannabinoid, Over The Counter
Cleared on Feb 12, 2026 as substantially equivalent to K223162 (Healgen Scientific,, LLC, 2023) after a 185-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Feb 12, 2026
- Review
- 185 days
- Class
- Class II
- Product code
- NFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K923386 (1992). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK923386 THC Urine CalibratorsDiagnostic Reagents, Inc. · 1992
- 4 generations backK021449 Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · Recalled
- 3 generations backK110239 Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2011
- 2 generations backK141320 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid…Lin-Zhi International, Inc. · 2015
- 1 generation backK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
- This deviceK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923386 | THC Urine Calibrators | Diagnostic Reagents, Inc. | 1992 | — |
| −4 | K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | 1 |
| −3 | K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control | Lin-Zhi International, Inc. | 2011 | — |
| −2 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids… | Lin-Zhi International, Inc. | 2015 | — |
| −1 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… | Healgen Scientific,, LLC | 2023 | — |
| 0 (this device) | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid… | Healgen Scientific,, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFW device
- #1 K231978 BioSieve™ Marijuana Test Panel 50; BioSieve™…score 8.6 · 10 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTSummary page 5…Toxicology MKU 21 CFR, 862.3220 Cotinine Test System Toxicology 5. Predicate Devices: Healgen® Accurate Oral Fluid Drug Test, K223162 6. Intended Use The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow chromatographic immunoassay for the… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All NFW devicesNFW Test, Cannabinoid, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NFW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NFW
Too few NFW 510(k)s in any year since 2007 to give a median.
Recalls per year · NFW
No recall names NFW since 2007.
Adverse event reports per year · NFW
1in 2025
MAUDE reports naming product code NFW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow chromatographic immunoassay for the qualitative detection of cotinine (COT) and/or marijuana (THC) in oral fluid at the following cut-off concentrations: Test Calibrator Cut-off (ng/mL) Cotinine (COT) (-) Cotinine 30 Marijuana (THC) Delta-9-Tetrahydrocannabinol 40 This test provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by…
Read the full statement (175 words)
The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow chromatographic immunoassay for the
qualitative detection of cotinine (COT) and/or marijuana (THC) in oral fluid at the following cut-off concentrations:
Test Calibrator Cut-off (ng/mL)
Cotinine (COT) (-) Cotinine 30
Marijuana (THC) Delta-9-Tetrahydrocannabinol 40
This test provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by
this drug test. Liquid chromatography mass spectrometry (LC/MS) is the preferred method for the confirmation test.
The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the
qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations
listed below and their metabolites:
Test Calibrator Cut-off (ng/mL)
Cotinine (COT) (-) Cotinine 30
Marijuana (THC) Delta-9-Tetrahydrocannabinol 40
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in
order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid
chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252523: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252523
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026